Collaborative Islet Transplant Registry (CITR)

2010 Annual Report Exhibits

Prepared by:

CITR Coordinating Center

The EMMES Corporation

Rockville, MD

Sponsored by:

National Institute of Diabetes & Digestive & Kidney Diseases

National Institutes of Health

Juvenile Diabetes Research Foundation

Datafile Closure: March 21, 2011

Collaborative Islet Transplant

Registry 2010

Follow-up time after initial infusion for

each recipient. Top: islet after kidney

(N=65), bottom: islet alone (N=347).

Yellow: insulin independence; green:

insulin-using with graft function (70%

average reduction in daily insulin use

from baseline); black: no islet function;

gray: missing data. Red marks indicate

re-infusions. Pie charts show percent of

all follow-up time with insulin

independence.

Table of Contents

Chapter 1: Islet Transplant Activity

Chapter 2: Recipient and Donor Characteristics

Chapter 3: Pancreas Procurement, Islet Processing, and Infusion

Characteristics

Chapter 4: Immunosuppression and Other Medications

Chapter 5: Graft Function

Chapter 6: Liver, Kidney, Lipid, and PRA Effects

Chapter 7: Adverse Events

Chapter 8: Registry Data Quality Review

CITR Coordinating Center

CITR Committees

Chapter 1: Islet Transplant Activity

CITR Recipients, Infusions and Donors byNIDDK/JDRF Sites and by ITA/IAK/SIK

Consented, Registered and First Infused in 1999-2009

Cumulative Enrollment in CITR

Islet Transplant Centers Reporting Data to CITRParticipating North American Centers 1999-2009

A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008C - CITR Centers with no islet allograft infusions in 2008D - CITR Coordinating Center

Islet Transplant Centers Reporting Data to CITRParticipating European Centers 1999-2009

A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008

B - CITR Centers with data reports pending

Islet Transplant Centers Reporting Data to CITRParticipating Australian Centers 1999-2009

A - CITR Centers with at least one islet allograft infusion procedure conducted in 2008

C - CITR Centers with no islet allograft infusions in 2008

Number of Islet Transplantation Centers Performing Islet Allografts per Year and Number with Data Entered in CITR Database

All North American Islet Transplant Centers 1999-2009

Total Number of Islet Allograft Recipients, Recipients at CITR-Participating Centers, and Recipients with Detailed Data Reported to CITR by Year of First Islet Allograft Infusion

Allograft recipients at North American Islet Transplant Centers 1999-2009

Total Number of Islet Allograft Recipients and Recipients with Detailed Data Reported to CITR by Year of First Islet Allograft Infusion

CITR-Participating European and Australian JDRF Centers 1999-2009

Total Number of Islet Allograft Infusion Procedures Performed andNumber with Data Reported to CITR

CITR-Participating North American Islet Transplant Centers 1999-2009

Total Number of Islet Allograft Infusion Procedures Performed and Number with Data Reported to CITR

CITR-Participating European and Australian JDRF Centers 1999-2009

Islet Allograft Infusions by Infusion Sequence Number and YearCITR-Participating North American and JDRF Centers, 1999-2009

Islet Allograft Recipients by Total Infusions to Date and YearCITR-Participating North American and JDRF Centers, 1999-2009

Total Number of Islet Allograft Infusions Per Recipient:CITR-Participating North American and JDRF Centers, 1999-2009

Total Number of Deceased Donors per Islet Allograft InfusionCITR-Participating North American and JDRF Centers, 1999-2009

Allograft Islet Alone and Islet After Kidney and Simultaneous Islet-Kidney Autograft Recipients

Participating North American and JDRF Centers, 1999-2009

Chapter 2: Recipient and Donor Characteristics

Recipient Demographics

Recipient Demographics (continued)

Recipient Characteristics at First Infusion

Recipient Diabetes Characteristics and Medical History

Recipient Diabetes Characteristics and Medical History (continued)

Recipient Diabetes Characteristics and Medical History (continued)

Recipient Diabetes Characteristics and Medical History (continued)

Recipient Autoantibodies and Sensitization at First Infusion

Recipient Autoantibodies and Sensitization at First Infusion (continued)

Recipient Infectious Disease Testing at First Infusion

Recipient Characteristics Prior to First Infusion by Total Number of Infusions Received

Recipient Baseline Autoantibodies by Total Infusions Received

Recipient Laboratory Values at First Infusion

Donor Demographics

Donor Characteristics

Donor Characteristics (continued)

Donor Hospitalization

Donor Hospitalization (continued)

Donor Hospitalization (continued)

Donor Serology

Donor Laboratory Data

Organ Crossmatch Results

Chapter 3: Pancreas Procurement, Islet processing and Infusion

Characteristics

Islet Processing Summary

Islet Processing Summary (continued)

Pancreas Digestion Combinations Involving Thermolysin/Pulmozyme

Final Islet Preparation Microbiology (Positive)

Cold Ischemia Information

Islet Product Characteristics

Islet Product Characteristics by Infusion Sequence

Islet Product Characteristics by Infusion Sequence (continued)

Islet Characteristics by Pancreas Preservation Method

Relationship between (Categorical) Islet Predictors and Final Islet Product Characteristics

Significant Correlations (p<0.05) between Islet Product Characteristics and (Continuous) Predictors

Significant Correlations (p<0.05) between Islet Product Characteristics and (Continuous) Predictors (continued)

Significant Correlations (p<0.05) between Islet Product Characteristics and (Continuous) Predictors (continued)

Significant Correlations (p<0.05) between Islet Product Characteristics and (Continuous) Predictors (continued)

Chapter 4: Immunosuppression and other Medications

Immunosuppression by Transplant Type, Era and Follow-up

Immunosuppression by Transplant Type, Era and Follow-up (continued)

Biologic Agents Used Peri-Infusion

Immunosuppression Categories & Agents, by Transplant Type and Follow-up

Chapter 5: Graft Function

First Achievement of Insulin Independence Post First Infusion (Regardless of total number of infusions;

censored at final graft loss or end of follow-up)

Achievement of Insulin Independence Post Last Infusion (Censored at final graft loss or end of follow-up)

Retention of Insulin Independence Post Last Infusion(Censored at final graft loss or end of follow-up)

Prevalence of Insulin Independence Post Last Infusion

Prevalence of Insulin Independence Post Last Infusion (continued)

Retention of C-peptide ≥0.3 ng/mL Post Last Infusion(Censored at end of follow-up)

Retention of C-peptide ≥0.3 ng/mL Post Last Infusion(Censored at end of follow-up)

(continued)

Re-Infusion(All infusions)

Fasting blood glucose 60-150 mg/mL post last infusion

HbA1c<6.5% or drop by 2% post last infusion

Absence of severe hypoglycemia post last infusion

Insulin dose (U/day) post last infusion

Fasting C-peptide (ng/ml) post last infusion

HbA1c (%) post last infusion

Fasting blood glucose (mg/dl) post last infusion

Association of C-peptide level (ng/mL) with other primary outcomes. At years 1-5 post last infusion

Insulin use (U/day) according to concurrent C-peptide levelYears 1-5 post last infusion (pooled)

Chapter 6: Liver, Kidney, Lipid and PRA Effects

ALT(IU/L) by Infusion Type and Era

AST(IU/L) by Infusion Type and Era

Alkaline Phosphatase (IU/L) by Infusion Type and Era

Total bilirubin (mg/dL) by Infusion Type and Era

Total Cholesterol (mg/dL) by Infusion Type and Era

HDL (mg/dL) by Infusion Type and Era

LDL (mg/dL) by Infusion Type and Era

Triglycerides (mg/dL) by Infusion Type and Era

Serum Creatinine (mg/dL) by Infusion Type and Era

Percent of Recipients with a 30% Increase in Serum Creatinine

at Each Follow-up Time Point by Infusion Type and Era

Cockgroft-Gault Calculated Clearance (mL/min/1.73m2)

by Infusion Type and Era

MDRD Estimated Creatinine Clearance (mL/min/1.73m2) by Infusion Type and Era

Chronic Kidney Disease Collaboration (CKD-EPI)Estimated GFR(mL/min/1.73m2) by Infusion Type and Era

Class 1 PRA and its Percent Change from First Infusion

Class 1 PRA Post Last Infusion by Graft Lossfor Islet Alone Recipients

AST (IU/L) by Immunosuppression Categories

Alkaline phosphatase (II/L) by Immunosuppression Categories

BUN (IU/L) by Immunosuppression Categories

Bilirubin (mg/dL) by Immunosuppression Categories

Total cholesterol (mg/dL) by Immunosuppression Categories

HDL (mg/dL) by Immunosuppression Categories

LDL (mg/dL) by Immunosuppression Categories

Triglycerides (mg/dL) by Immunosuppression Categories

Serum creatinine (mg/L) by Immunosuppression Categories

CKD-EPI-GFR (mL/min/1.7m**2) by Immunosuppression Categories

 

Class 1 PRA (%) by Immunosuppression Categories

Class 2 PRA (%) by Immunosuppression Categories

Recipient body weight (kg) by Immunosuppression Categories

 

Chapter 7: Adverse Events

Adverse Events (AEs) in Days 0-30 Post First Infusion

Adverse Events (AEs) in Days 0-30 Post First Infusion (continued)

Serious Adverse Events (SAEs) in Days 0-30 Post First Infusion

Serious Adverse Events (SAEs) in Days 0-30 Post First Infusion (continued)

Serious Adverse Events (SAEs) in Days 0-30 Post First Infusion (continued)

Adverse Event (AEs) in Year 1 Post First Infusion

Recipients with a Serious Adverse Event (SAE) in Year 1 Post First Infusion

Recipients with an Adverse Event (AE) any time post islet transplantation

Recipients with a Serious Adverse Event (SAE) any time post islet transplantation

Worst Outcome of Any Adverse Events per Recipient

All Adverse Events Following Islet Transplant in order by frequency, with final outcome

All Adverse Events Following Islet Transplant in order by frequency, with final outcome (continued)

All Adverse Events Following Islet Transplant in order by frequency, with final outcome (continued)

All Adverse Events Following Islet Transplant in order by frequency, with final outcome (continued)

SAE Criteria

ITA: Incidence of Post-Transplant AEs Related to Infusion Procedure

ITA: Incidence of Post-Transplant AEs Related toImmunosuppression Therapy

IAK/SIK: Incidence of Post-Transplant AEs Related to Infusion Procedure

IAK/SIK: Incidence of Post-Transplant AEs related to Immunosuppression Therapy

Incidence of AEs and SAEs per Recipient by Type of Transplant and Era

Summary of neoplasms reported post islet transplantationCITR data as of 3/21/2011

Deaths

Deaths

Life-Threatening Events

1999-2003 2004-2006 2007-2009 p

Life-threatening event 64/246 (26%)

54 / 190 (28%)

14 / 135 (11%)

0.02

Life-Threatening Events (in System/Organ Class Order)

System/Organ Class MedDRA Preferred Term

Typeof

Transplant Era

Months post

infusion 1

Relatedto

InfusionProcedure?

Related toImmunosuppression

Therapy?Blood and lymphatic system disorders

Anaemia ITA 2004-2006 3.3 Unlikely related

Possibly related Anaemia ITA 2004-2006 1.9 Unlikely related Unlikely relatedAnaemia IAK/SIK 1999-2003 0.9 Possibly related Unlikely relatedAnaemia IAK/SIK 1999-2003 46.6 Not related Possibly relatedBlood disorder IAK/SIK 1999-2003 8.5 Not related Unlikely relatedLymphopenia ITA 2004-2006 0.0 Not related RelatedLymphopenia ITA 2004-2006 0.0 Not related RelatedLymphopenia ITA 2004-2006 -1.2 Not related RelatedLymphopenia ITA 2004-2006 0.0 Not related RelatedLymphopenia IAK/SIK 1999-2003 18.6 Unlikely related Possibly related

Cardiac disorders Cardio-respiratory arrest ITA 1999-2003 28.2 Not related Not relatedMyocardial ischaemia ITA 1999-2003 0.0 Possibly related Possibly relatedMyocardial ischaemia ITA 2007-2010 4.1Myocardial ischaemia ITA 2007-2010 0.7 Not related Not relatedMyocardial ischaemia IAK/SIK 2007-2010 26.7 Unlikely related Unlikely related

Gastrointestinal disorders Gastrointestinal haemorrhage IAK/SIK 2004-2006 0.0 Related Unlikely relatedGastrointestinal obstruction ITA 2004-2006 1.6 Related Not relatedPeritoneal haemorrhage ITA 1999-2003 1.1 Related Possibly relatedPeritoneal haemorrhage ITA 1999-2003 1.0 Related Unlikely relatedPeritoneal haemorrhage ITA 2004-2006 0.0 Related Not relatedPeritoneal haemorrhage ITA 2007-2010 6.7 Related Unlikely relatedPeritoneal haemorrhage ITA 1999-2003 49.8 Related Not relatedPeritoneal haemorrhage ITA 1999-2003 17.2 Related Not relatedPeritoneal haemorrhage ITA 2007-2010 8.2 Related Not related

Life-Threatening Events (in System/Organ Class Order) Continued

System/Organ ClassMedDRA Preferred

Term

Typeof

Transplant Era

Months post

infusion 1

Relatedto

InfusionProcedure?

Related toImmunosuppression

Therapy?Peritoneal haemorrhage IAK/SIK 1999-2003 0.0 Related Not relatedPeritoneal haemorrhage IAK/SIK 2004-2006 15.2 Related Not related

General disorders and administration site conditions

Death ITA 2007-2010 19.8 Possibly related Possibly related

Death IAK/SIK 1999-2003 43.9 Not related Not relatedHepatobiliary disorders Cholecystitis ITA 1999-2003 12.4 Possibly related Unlikely related

Portal vein thrombosis ITA 1999-2003 3.3 Related Not relatedPortal vein thrombosis ITA 2004-2006 0.0 Related Not related

Immune system disorders Hypersensitivity ITA 2004-2006 29.7 Not related RelatedHypersensitivity ITA 1999-2003 34.0 Unlikely related Possibly relatedHypersensitivity IAK/SIK 1999-2003 10.5 Not related Unlikely related

Infections and infestations Infection ITA 2004-2006 20.7 Not related Possibly relatedInfection ITA 2004-2006 33.9 Not related Possibly relatedInfection ITA 2004-2006 1.6 Related Not relatedInfection ITA 2004-2006 5.9 Possibly related Possibly relatedInfection ITA 1999-2003 33.2 Unlikely related Possibly relatedOpportunistic infection ITA 2004-2006 60.3 Unlikely related RelatedOpportunistic infection IAK/SIK 2007-2010 12.8 Not related Possibly related

Life-Threatening Events (in System/Organ Class Order) Continued

Investigations Blood alkaline phosphatase ITA 1999-2003 0.2 Possibly related Unlikely relatedBlood alkaline phosphatase ITA 2004-2006 0.1 Possibly related Unlikely relatedBlood alkaline phosphatase ITA 2004-2006 0.1 Possibly related Unlikely relatedGranulocytes abnormal ITA 1999-2003 1.8 Unlikely related RelatedGranulocytes abnormal ITA 1999-2003 1.9 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 37.8 Not related RelatedGranulocytes abnormal ITA 1999-2003 2.5 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 26.7 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 1.4 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 9.8 Not related RelatedGranulocytes abnormal ITA 1999-2003 4.1 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 1.7 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 49.2 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 0.9 Unlikely related Possibly relatedGranulocytes abnormal ITA 1999-2003 0.5 Not related Possibly relatedGranulocytes abnormal ITA 1999-2003 19.7 Unlikely related Possibly relatedGranulocytes abnormal ITA 1999-2003 0.1 Unlikely related Possibly relatedGranulocytes abnormal ITA 1999-2003 0.1 Unlikely related Possibly relatedGranulocytes abnormal ITA 2004-2006 0.1 Related RelatedGranulocytes abnormal ITA 2004-2006 0.2 Not related RelatedGranulocytes abnormal ITA 2004-2006 0.1 Unlikely related RelatedGranulocytes abnormal ITA 2004-2006 3.4 Not related Possibly relatedGranulocytes abnormal ITA 2004-2006 0.7 Unlikely related Possibly relatedGranulocytes abnormal ITA 2004-2006 0.3 Unlikely related Possibly relatedGranulocytes abnormal ITA 2004-2006 0.7 Not related RelatedGranulocytes abnormal ITA 2004-2006 5.2 Not related RelatedGranulocytes abnormal ITA 2004-2006 3.6 Not related RelatedGranulocytes abnormal ITA 2007-2010 4.8 Unlikely related RelatedGranulocytes abnormal ITA 2007-2010 0.1 Unlikely related Possibly relatedGranulocytes abnormal IAK/SIK 1999-2003 3.1 Not related Possibly relatedGranulocytes abnormal IAK/SIK 2004-2006 3.8 Not related Possibly relatedGranulocytes abnormal IAK/SIK 2004-2006 2.5 Not related Possibly relatedGranulocytes abnormal IAK/SIK 2004-2006 7.9 Not related Possibly relatedLiver function test abnormal ITA 1999-2003 0.3 Possibly related Unlikely relatedLiver function test abnormal ITA 1999-2003 0.2 Possibly related Unlikely related

System/Organ Class MedDRA Preferred Term

Typeof

Transplant Era

Months post

infusion 1

Relatedto

InfusionProcedure?

Related toImmunosuppression

Therapy?

Life-Threatening Events (in System/Organ Class Order) Continued

Liver function test abnormal ITA 1999-2003 0.2 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 1.1 Related Related

Liver function test abnormal ITA 1999-2003 0.0 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.3 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.2 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.1 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.0 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.1 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.1 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.1 Related Not related

Liver function test abnormal ITA 1999-2003 12.9 Possibly related Unlikely related

Liver function test abnormal ITA 1999-2003 0.1 Possibly related Unlikely related

Liver function test abnormal ITA 2004-2006 0.1 Possibly related Unlikely related

Liver function test abnormal ITA 2004-2006 0.3 Possibly related Unlikely related

Liver function test abnormal ITA 2004-2006 0.3 Possibly related Unlikely related

Liver function test abnormal ITA 2004-2006 0.2 Possibly related Unlikely related

Liver function test abnormal ITA 2004-2006 0.0 Possibly related Unlikely related

Liver function test abnormal ITA 2004-2006 0.2 Possibly related Possibly related

Liver function test abnormal ITA 2004-2006 0.1 Possibly related Possibly related

Liver function test abnormal ITA 2004-2006 0.0 Possibly related Unlikely related

Troponin I IAK/SIK 1999-2003 57.1 Not related Not related

System/Organ Class MedDRA Preferred Term

Typeof

Transplant Era

Months post

infusion 1

Relatedto

InfusionProcedure?

Related toImmunosuppression

Therapy?

Life-Threatening Events (in System/Organ Class Order) Continued

System/Organ Class MedDRA Preferred Term

Typeof

Transplant Era

Months post

infusion 1

Relatedto

InfusionProcedure?

Related toImmunosuppression

Therapy?Metabolism and nutrition disorders

Hypoglycaemia ITA 1999-2003 26.9 Not related Not related

Hypoglycaemia ITA 1999-2003 8.7 Not related Not relatedHypoglycaemia ITA 1999-2003 14.9 Not related Not relatedHypoglycaemia ITA 1999-2003 11.1 Not related Not relatedHypoglycaemia ITA 2004-2006 34.9 Not related Not relatedHypoglycaemia ITA 1999-2003 0.4 Unlikely relatedHypoglycaemia ITA 2004-2006 12.4 Not related Not relatedHypoglycaemia ITA 2004-2006 11.3 Not related Possibly relatedHypoglycaemia ITA 2004-2006 2.6 Related Not relatedHypoglycaemia ITA 2004-2006 -8.1 Not related Not relatedHypoglycaemia ITA 2004-2006 0.0 Unlikely related Unlikely relatedHypoglycaemia ITA 2007-2010 16.5 Unlikely related Unlikely relatedHypophosphataemia ITA 2004-2006 2.3 Not related Possibly relatedKetoacidosis ITA 2007-2010 4.5 Possibly related Unlikely related

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm malignant ITA 1999-2003 26.9 Not related Possibly related

Neoplasm malignant ITA 2004-2006 4.4 Not related Not relatedNeoplasm malignant ITA 2004-2006 22.9 Not related Possibly relatedNeoplasm malignant ITA 2004-2006 4.6 Unlikely related Possibly relatedNeoplasm malignant ITA 1999-2003 105.0 Not related Possibly related

Nervous system disorders Cerebral ischaemia ITA 1999-2003 0.2 Unlikely related Unlikely relatedCerebral ischaemia IAK/SIK 1999-2003 66.6 Unlikely related Not relatedCerebral ischaemia IAK/SIK 2007-2010 13.2 Not related Not related

Psychiatric disorders Insomnia ITA 1999-2003 19.7 Not related RelatedRenal and urinary disorders Proteinuria ITA 2004-2006 24.3 Not related Related

Proteinuria IAK/SIK 2004-2006 28.3 Not related Possibly relatedRenal failure ITA 1999-2003 8.1 Unlikely related Possibly related

Respiratory, thoracic and mediastinal disorders

Aspiration ITA 2007-2010 0.1 Possibly related Possibly related

Pneumonitis IAK/SIK 1999-2003 0.6 Not related Possibly relatedVascular disorders Haematoma ITA 2004-2006 0.0 Related Not related

Life-Threatening Events (in System/Organ Class Order) Continued

System/Organ Class MedDRA Preferred Term

Typeof

Transplant Era

Months post

infusion 1

Relatedto

InfusionProcedure?

Related toImmunosuppression

Therapy?

Haematoma IAK/SIK 1999-2003 0.0 Related Not related

Haemorrhage ITA 1999-2003 0.0 Possibly related Unlikely related

Haemorrhage IAK/SIK 2004-2006 5.4 Related Unlikely related

Hypertension ITA 1999-2003 50.0 Not related Possibly related

Life-Threatening Events (in System/Organ Class Order) Continued

C. Outcomes of life-threatening events Total

Outcome

FatalNot

recovered RecoveredRecovered

with seq UnknownN Row% Row% Row% Row% Row%

System/Organ Class Preferred Term4 . . 100.0 . .Blood and lymphatic system disorders Anaemia

Blood disorder 1 . . 100.0 . .Lymphopenia 5 . . 100.0 . .

Cardiac disorders Cardio-respiratory arrest 1 100.0 . . . .Myocardial ischaemia 4 . . 50.0 50.0 .

Gastrointestinal disorders Gastrointestinal haemorrhage 1 . . 100.0 . .Gastrointestinal obstruction 1 . . 100.0 . .Peritoneal haemorrhage 9 . . 100.0 . .

General disorders and administration site conditions

Death2 100.0 . . . .

Hepatobiliary disorders Cholecystitis 1 . . 100.0 . .Portal vein thrombosis 2 . . 100.0 . .

Immune system disorders Hypersensitivity 3 . . 33.3 33.3 33.3Infections and infestations Infection 5 . . 40.0 60.0 .

Opportunistic infection 2 . . 100.0 . .Investigations Blood alkaline phosphatase 3 . . 100.0 . .

Granulocytes abnormal 30 . 3.3 96.7 . .Liver function test abnormal 22 . . 95.5 4.5 .Troponin I 1 . . 100.0 . .

Metabolism and nutrition disorders Hypoglycaemia 12 . . 100.0 . .Hypophosphataemia 1 . . 100.0 . .Ketoacidosis 1 . . 100.0 . .

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm malignant5 . 40.0 20.0 40.0 .

Nervous system disorders Cerebral ischaemia 3 . 33.3 . 66.7 .Psychiatric disorders Insomnia 1 . . 100.0 . .Renal and urinary disorders Proteinuria 2 . 50.0 50.0 . .

Renal failure 1 . . . 100.0 .Respiratory, thoracic and mediastinal disorders

Aspiration 1 . . 100.0 . .Pneumonitis 1 100.0 . . . .

Vascular disorders Haematoma 2 . . 100.0 . .Haemorrhage 2 . . 100.0 . .Hypertension 1 . . 100.0 . .

Chapter 8: Registry Data Quality Review

Total number of patients expected at each follow-up visit post last infusion

Missing Data for Insulin Independence by Era and Type of Transplant

Missing Data for Fasting C-Peptide by Era and Type of Transplant

Data for Hemoglobin A1c by Era and Type of Transplant

Missing Data for Fasting Blood Glucose by Era and Type of Transplant

Missing Data for Severe HypoGlycemia by Era and Type of Transplant

 Missing Data for BMI

by Era and Type of Transplant

Missing Data for Clarke Score by Era and Type of Transplant

Missing Data for Ryan Hypo by Era and Type of Transplant

Missing Data for C-Peptide AUC by Era and Type of Transplant

Missing Data for Cockcroft-Gaullt by Era and Type of Transplant

Missing Data for Creatinine by Era and Type of Transplant

Missing Data for Cholesterol by Era and Type of Transplant

 Missing Data for HDL

by Era and Type of Transplant

Missing Data for LDL by Era and Type of Transplant

Missing Data for Triglycerides by Era and Type of Transplant

Missing Data for Bilirubin by Era and Type of Transplant

Missing Data for ALT by Era and Type of Transplant

Missing Data for AST by Era and Type of Transplant

Missing Data for Alkaline Phosphate by Era and Type of Transplant

Appendices

CITR Coordinating Center(July 2008 – July 2009)

PI: Franca Benedicty Barton

Co-PI: Donald Stablein

Yamini Babu

Ruth Danoff

Jodi DeStefano

Andrew Heitman

Krista Huang

Steve Wease

Tina Winters

Islet Transplant Centers

Baylor College of Medicine/

The Methodist Hospital

Houston, Texas, USA

PI: John A. Goss

Baylor Regional Transplant Institute

Dallas, Texas, USA

PI: Marlon Levy

Benaroya Research Institute

Seattle, Washington, USA

PI: Carla Greenbaum

Carolinas Medical Center

Charlotte, North Carolina, USA

PI: Paul Gores

Center for Islet Transplantation at Harvard

Medical School

Boston, Massachusetts, USA

PI: Enrico Cagliero

Columbia University

New York, New York, USA

PI: Mark A. Hardy

Emory Transplant Center

Atlanta, Georgia, USA

PI: Mark Rigby

GenevaGRAGIL Network

Geneva, Switzerland

PI: Thierry Berney

Lille University Hospital

Lille Cedex, France

PI: Francois Pattou

Mayo Clinic

Rochester, Minnesota, USA

PI: Yogish Kudva

NIH Clinical Transplant Center

Bethesda, Maryland, USA

PI: David Harlan

Northwestern University

Chicago, Illinois, USA

PI: Dixon Kaufman

San Raffaele Institute

Milan, Italy

PI: Antonio Secchi

Scripps Health

La Jolla, California, USA

PI: Christopher Marsh

Southern California Islet Consortium (SCIC)

Duarte, California, USA

PI: Fouad Kandeel

St. Vincent’s Institute

Fitzroy, Victoria, Australia

PI: Tom Kay

Swedish Medical Center

Seattle, Washington, USA

PI: William Marks

Toronto General Hospital

Toronto, Ontario, CANADA

PI: Mark Cattral

The University of Tennessee, Memphis

Memphis, Tennessee, USA

PI: A. Osama Gaber

UMass Memorial Hospital

Worcester, Massachusetts, USA

PI: Aldo Rossini

University of Alabama

Birmingham, Alabama, USA

PI: Juan Luis Contreras

University of Alberta

Edmonton, Alberta, CANADA

PI: A. M. James Shapiro

Co-PI: Peter Senior

Parastoo Dinyari

University of California,

San Francisco

San Francisco, California, USA

PI: Peter Stock

Co-PI: Andrew Posselt

University of Chicago

Chicago, Illinois, USA

PI: Marc Garfinkel

University of Colorado Health Sciences

Center

Auora, Colorado, USA

PI: Alexander Wiseman

University of Illinois, Chicago

Chicago, Illinois, USA

PI: Jose Oberholzer

Co-PI: Enrico Benedetti

Co-PI: James Bui

Co-PI: Charles Owens

University of Miami

Miami, Florida, USA

PI: Rodolfo Alejandro

Co-PI: Camillo Ricordi

University of Minnesota

Minneapolis, Minnesota, USA

PI: Bernhard J. Hering

University of Nebraska

Omaha, Nebraska, USA

PI: R. Brian Stevens

University of Pennsylvania

Philadelphia, Pennsylvania, USA

PI: Ali Naji

University of Virginia

Charlottesville, Virginia, USA

PI: Kenneth Brayman

University of Wisconsin

Madison, Wisconsin, USA

PI: Jon Odorico

Virginia Commonwealth University

Richmond, Virginia, USA

PI: Adrian Cotterell

University of Pennsylvania

Washington University,

St. Louis

St. Louis, Missouri, USA

PI: Niraj Desai

Westmead Hospital

Wentworthville, NSW, Australia

PI: Philip Oconnell

CITR Committees

Scientific Advisory Committee (SAC)

Compliance Committee (2008)

Data Elements Committee (2008)

Publications/Presentations Committee (2008)

Transplant Coordinators’/Data Managers’ Committee (2008)

CITR Scientific Advisory Committee (SAC)

Chair: Bernhard J. Hering

Michael Appel

Franca Benedicty Barton

Michael Cecka

Philip E. Cryer

Olle Korsgren

Maureen McBride

Jerry P. Palmer

Camillo Ricordi

Gordon Weir

CITR Compliance Committee (2008)

Chair: Fouad Kandeel

Michael Appel

Parastoo Dinyari

Albert Hwa

Carol Kramer

Joan Martellotto

Violetta Raverdi

Marti Sears

Elyse Stuart

CITR Data Elements Committee (2008)

Chair: Marti Sears

David Baidal

Enrico Cagliero

Marc Garfinkel

Fouad Kandeel

Dixon Kaufman

Robert Ketchum

Francois Pattou

David Sutherland

CITR Publications/Presentations Committee (2008)

Chair: Rodolfo Alejandro

Michael Appel

Nancy Bridges

Shari Messinger Cayetano

Brian Flanagan

Elizabeth Holbrook

Robert Ketchum

Bashoo Naziruddin

Craig Smith

CITR Transplant Coordinators’/Data Managers’ Committee (2008)

Chair: Parastoo Dinyari

Jarrett Anderson

David Baidal

LeAnn Batterson

Meyer Belzer

Elsa Boely

Jane Fasbender

Courtney Garbee

Susan George

Debbie Grice

Darrell Grimes

Jeannette Hacker

Celia Hartigan

Elizabeth Holbrook

Nancy Radke

Violeta Raverdy

Marilyn Reeve

Kristi Schneider

Marti Sears

Jill Sheedy

KD Shiang

Elyse Stuart

Pat Swanson

Heather Turgeon

Patricia Wilson

Dona Winborne

Piotr Witkowski

Robin Jevne

Jenny Joseph

Debra Kemp

Mark Lockwood

Eileen Markmann

Joan Martellotto

Marli McCulloch-Olson

Joan McElroy

Melissa McGraw

Suzanne Miller

Bashoo Naziruddin

Lori Otken

Maral Palanjian

Jamen Parkey

CITR Allografts

Recipients with C-Peptide ≥ 0.3 Pre-Infusion